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FDA withdraws emergency use authorization of COVID drug because it is unlikely to be effective against new variants

Sarah Silbiger/Getty Images

(WASHINGTON) -- The U.S. Food and Drug Administration said Thursday it is withdrawing its emergency use authorization of a COVID-19 antibody therapy as a prevention tool because it is unlikely to be effective against variants that are currently circulating.

Evusheld, which is made by British-Swedish pharmaceutical and biotechnology company, AstraZeneca, was first authorized in December 2021 as pre-exposure prophylaxis against the virus for those who are immunocompromised and less likely to generate antibodies from vaccination.

However, the FDA said the medication does not neutralize several omicron subvariants including BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and XBB.1.5.

According to the Centers for Disease Control and Prevention, these subvariants make up at least an estimated 90% of cases in the U.S.

"This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants," the FDA said in a press release.

"Today's action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product," the press release continued.

The FDA has been warning for months that Evusheld might not be very effective, starting in February 2022 when data showed a higher dose may be able to prevent against infection from omicron subvariants BA.1 and BA.1.1 than the originally approved dose.

As recently as Jan. 6 of this year, the FDA said it didn't believe Evusehld would be able to neutralize the XBB.1.5 subvariant "because of its similarity to variants that are not neutralized by Evusheld."

AstraZeneca did not immediately reply to ABC News' request for comment. In a statement, the pharmaceutical company said it is aware of the decision and that it is cooperating with the FDA.

"AstraZeneca will continue to work with the FDA and other health authorities to collect, assess and share relevant data regarding Evusheld and SARS-CoV-2 variants," the statement read. "Evusheld currently remains authorized in other countries where it is approved for COVID-19 pre-exposure prophylaxis and treatment, including the EU and Japan."

Evusheld is a type of monoclonal antibody treatment, which are a cocktail of antibodies that are manufactured in a lab and mimic the antibodies the body naturally creates when fighting the virus.

They bind to the spike protein, which prevents the virus from attaching to -- and infecting -- cells.

The FDA said if someone tests positive for COVID-19 and develops symptoms, they should contact their primary care provider and, if needed, ask to receive antiviral medications Paxlovid, molnupriavir or remdesivir, which work against the currently circulating variants.

Despite Evusheld losing emergency use authorization status, the FDA urged providers not to discard their doses of the drug.

"The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future," the FDA said in its press release.

Copyright © 2023, ABC Audio. All rights reserved.


Peloton instructor reveals breast cancer diagnosis at age 35

Courtesy of Peloton

(NEW YORK) -- A Peloton instructor is opening up for the first time about her battle with breast cancer, revealing she got a lifesaving second opinion after discovering a lump on her breast.

Leanne Hainsby, a 35-year-old cycling instructor for the fitness company, revealed on Instagram that she was diagnosed with breast cancer last August.

She wrote that she self-discovered a lump on her breast and was told "everything was OK" at a doctor's appointment that same day.

"I trusted my gut and got a second opinion. That saved my life," Hainsby wrote, adding to her followers, "Check, and check again."

Hainsby, who is based in London, said that in the past six months since her diagnosis, she has undergone surgery as well as 12 weeks of chemotherapy.

She said she will next undergo two weeks of radiation.

"Treatment will continue for a long time for me, hospital visits are the norm, and I focus on one step at a time," wrote Hainsby, who did not share what stage of cancer she is battling.

Hainsby also shared that prior to chemotherapy, she underwent in-vitro fertilization, or IVF, which can be done if there is concern that the chemotherapy medicine may cause infertility.

"I was lucky enough to be given time ahead of chemotherapy to do a round of IVF," Hainsby wrote, adding of her and her partner, a fellow Peloton instructor, "We weren't mentally prepared, but we got it done and we're so grateful."

Hainsby's confirmation of her diagnosis at age 35 underscores the warning that breast cancer can impact women of all ages, though most breast cancers are diagnosed in women ages 50 and older, according to the Centers for Disease Control and Prevention.

In the United States, breast cancer is the second-most common cancer among women, with over 260,000 new cases reported in 2019, the latest data available, according to the CDC.

Although the risk for breast cancer in young women remains low, breast cancer found in young women can be more aggressive and more difficult to treat, Dr. Margaret Thompson, a doctor in breast services at Cleveland Clinic Florida, told ABC News in October.

Breast cancer can also be more difficult to spot in young women.

Younger breast tissue tends to be more dense so spotting tumors, even on mammograms, can be more challenging and may be misdiagnosed, according to the Cleveland Clinic.

Mammogram screenings are recommended once every two years for women age 50 to 74 years who have an average risk of breast cancer, according to U.S. Preventive Services Task Force guidelines.

Women ages 40 to 49 may choose to begin screening once every two years if they "place a higher value on the potential benefit than the potential harms" of the mammogram, according to the guidelines.

For women of all ages, when an ultrasound shows a concerning finding, a follow-up visit should be scheduled to discuss next steps with your healthcare provider.

Copyright © 2023, ABC Audio. All rights reserved.


Study finds autism rates have tripled among young kids: What to know

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(NEW YORK) -- Autism is on the rise among young children, according to a new study.

The study, published Thursday in the journal Pediatrics, found that autism rates tripled over the last 16 years.

Researchers at Rutgers University looked at more than 4,000 8-year-olds in the New York and New Jersey areas.

They said the sharp rise in autism rates is largely due to greater awareness, better diagnosis tools and a broader definition of autism. Researchers also noted the greatest increases in diagnoses were amongst affluent children, concluding that children in underserved communities are not getting the same access to medical resources.

Autism, also known as autism spectrum disorder, is defined by the Centers for Disease Control and Prevention as a "developmental disability that can cause significant social, communication and behavioral challenges."

On the national scale, around one in 44 children has been diagnosed with autism spectrum disorder, according to the CDC.

The disorder begins before a child turns 3 and can last through their lifetime, though symptoms may improve and vary, the CDC notes.

"You want to talk to your child’s pediatrician about this because early intervention makes a big difference," said Dr. Jennifer Ashton, ABC News chief medical correspondent, adding, "Remember, those children [with autism spectrum disorder] grow up to be teens and adults, so the more we can help them the better their outcomes can be."

What to know about autism

People with autism have a wide variety of traits affecting communication, behavior and socialization, according to the CDC.

The “spectrum” means that there’s a wide range of symptoms and severity.

A child of any race, socioeconomic status or ethnic group can get ASD. Boys, however, are four times more likely to be diagnosed with autism than girls based on a study of children aged 8 years old. Kids that have a sibling with autism, and especially a twin, are more likely to have autism. Those with developmental disabilities or genetic and chromosomal diseases such as Down syndrome are also more likely to have ASD. There is also evidence that kids born to older parents have an increased risk of autism, according to several studies.

Autism can be identified as early as infancy, although most children are diagnosed after the age of 2. There is no medical test to diagnose autism, so doctors watch a child's behavior and development to make a diagnosis, according to the CDC.

The American Academy of Pediatrics recommends all children be formally screened for autism spectrum disorder at their 18- and 24-month-old well-child visits. The AAP says pediatricians though will begin monitoring babies at their first well-child visit by observing their behaviors.

“It is those observations -- in combination with family history, health examinations, and parents' perspectives -- that help pediatric primary health care providers identify children at risk for ASD,” the AAP says on its website.

The CDC notes that in some cases people are not diagnosed with autism until they are teens or adults.

Experts say though that early detection of ASD is key, as is early intervention.

Early signs of autism in children may include, but are not limited to, little or no smiling and limited eye contact by 6 months; little to no babbling, pointing or response to their name by 12 months; and few or no meaningful two-word phrases by 24 months, according to the CDC.

Additional signs of autism may include delayed social interactions, exhibiting repetitive behaviors or showing a limited interest in activities and sensory issues like sensitivity to noise or sound.

“Someone might have the communication delay but may not have the motor skill delay,” said Dr. Jen Clark, a New York-based clinical psychologist and specialist in autism, told ABC News last year. “They may experience sounds and lights in a very different way than you and I would and sometimes they can experience a sensory overload and they may wear headphones and this will help to make the noise not as severe, but also they may avoid certain situations where it's just too overwhelming.”

Treatment comes in many different forms, from mental health therapy to occupational, physical and speech therapies. Sometimes medications can be helpful for things related to ASD, like mood problems or inability to focus.

Copyright © 2023, ABC Audio. All rights reserved.


FDA proposes allowing gay and bisexual monogamous men to donate blood

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(WASHINGTON) -- The U.S. Food and Drug Administration announced Friday it will ease blood donation restrictions on gay and bisexual men, allowing those in monogamous relationships to donate.

The policy change comes after years of urging by public health experts, blood banks and LGBTQ advocacy groups. The new policy would address future blood shortages and remove the stigma around gay men, experts say.

Additionally, the American Red Cross and the American Medical Association have both supported a risk-based approach to donor eligibility.

"Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day," said FDA Commissioner Robert M. Califf. "Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so."

Rather than a blanket ban due to sexual orientation, the relaxation of the rule would screen potential donors on their risk of contracting and transmitting HIV.

In 1985, in response to the HIV/AIDS crisis in the 1980s, the FDA banned all blood donations from men who have sex with men.

The policy did not change until 2015, when rules were slightly relaxed to allow this group of donors to give blood as long as they abstained from sex for one year. In 2020, amid severe blood shortages during the start of the COVID-19 pandemic, the FDA shortened the abstinence period to 90 days.

The policy change means gay and bisexual men in monogamous relationships can donate without abstaining from sex as long as they test HIV negative and are practicing safe sex.

It also means the U.S. will join several Western countries, including the United Kingdom, France, Greece and the Netherlands, which have recently either dropped bans or eased restrictions.

Last month, the FDA told ABC News the evidence analyzed so far will "likely support a policy transition" that focuses screening blood donations based on each person’s HIV risk.

In 2020, the FDA launched a study called ADVANCE to look into alternative solutions to its current policy. The FDA is currently reviewing research from the American Red Cross, OneBlood and Vitalant to determine if eligibility based on an individual's risk can replace the current time-based deferral system while maintaining the safety of the blood supply.

Experts say the updated policy will also help address the national blood shortage and, in turn, save lives. In January 2022, the American Red Cross said it was facing its worst blood shortage in more than a decade, although it is no longer in a crisis.

Despite the easing of rules, non-monogamous men are not allowed to donate even if they produce a negative HIV test, practice safe sex with condoms or take pre-exposure prophylaxis, or PrEP -- a daily pill containing two medications that prevent HIV-negative patients from being infected.

ABC News’ Sony Salzman and Kiara Alfonseca contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


TikTok-famous dad behind 'Enkyboys' dies at 35 following cancer battle

@enkyboys/TikTok

(NEW YORK) -- Randy Gonzalez, the Texas father behind the popular "Enkyboys" account on social media died Wednesday at age 35, his mother Beatrice Gonzalez and brother David Gonzalez confirmed to ABC News.

Gonzalez's death came less than one year after he announced he had been diagnosed with stage 4 colon cancer.

Gonzalez and his son Brice became famous on TikTok for their funny father-son comedy bits and dances.

"At first, we were kind of shy but we broke out of that shell because people love Brice so much and then they love the duo of the father and son, so we were just like, 'Let's go! Let's do it!'" Gonzalez told Good Morning America back in 2020 about the rise of "Enkyboys."

Last April, Gonzalez revealed in a video post that he had been diagnosed with stage 4 colon cancer in November 2021.

"I kept it to myself and I felt like it was selfish because I didn't want to tell everybody my business because it was personal. But I feel like I can use my situation to give awareness for young men like myself because I'm only 34, and they say it's very rare for a young guy like myself to catch colon cancer," Gonzalez said in the video at the time, adding that a doctor had told him he had a life expectancy between two and five years.

"I didn't know how to take it. You know, it was devastating," Gonzalez continued.

In the video, Gonzalez also opened up about one of his initial symptoms that led him to see a doctor in the first place.

"I want to help other people and start awareness for young men to go get checked for colon cancer, to go get a colonoscopy. How I figured out, I was having a problem with my upper abdomen and I was always in pain," he said. "And luckily, my wife told me to go get a colonoscopy because I was just gonna get an EGD [esophagogastoduodenoscopy] through my throat because they thought it was a ulcer or something. But long story short, I wanted to start awareness of colon cancer for young men to start, to go get checked in the early ages, 30 years old."

Since then, the "Enkyboys" social media accounts have featured posts aimed at raising colon cancer awareness, with Gonzalez sharing the symptoms he experienced, such as abdominal pain and constipation, and taking fans along as he underwent chemotherapy treatments.

According to the Centers for Disease Control and Prevention, colon or colorectal cancer is a type of cancer originating from polyps in the colon or rectum. In the U.S., it has become the second-leading cause of cancer-related deaths.

The disease can affect men and women of any racial and ethnic background. People at increased risk of developing colon cancer include individuals with a family history of colon polyps or colon cancer and those with bowel diseases like Crohn's disease or ulcerative colitis. Lifestyle can also play a role and increase a person's risk, such as a diet high in fat and low in fiber, the use of alcohol and tobacco and a lack of physical activity.

Last year, a major study showed that more young people, including more individuals of non-Hispanic Black and Hispanic descent and those between the ages of 20 and 29, have been getting diagnosed with late-stage colon cancer in recent years, prompting doctors to call for more early detection and colon cancer screenings of individuals younger than 50.

Who should get screened for colon cancer?

The U.S. Preventive Services Task Force and CDC currently recommend that people between the ages of 45 and 75 get regular colon cancer screenings, while those older than 75 should consult with their doctor before getting a screening. If at increased risk due to family history of colon polyps or colon cancer or for those with bowel diseases, screening may start before the age of 45, but this should be discussed with a doctor beforehand. A screening can consist of a stool test, a flexible sigmoidoscopy where a doctor places a tube in the rectum to check for polyps, a colonoscopy, or a CT colonography or virtual colonoscopy.

What are the symptoms of colon cancer?

An individual with colon cancer may not always exhibit symptoms initially, according to the CDC, and they can vary. Symptoms include:

  • Abdominal aches, pain or cramps
  • Bowel habit changes, including a feeling that the bowel does not empty entirely
  • Blood in the stool
  • Constipation
  • Diarrhea
  • Unexplained weight loss

Gonzalez is survived by his wife Kimberly and their three kids, son Brice and daughters Lauren and Nylah. Kimberley Gonzalez and her daughters also have their own TikTok and social media accounts called "Enkygirls."

Copyright © 2023, ABC Audio. All rights reserved.


Senior FDA official resigns in wake of 2022 infant formula shortage, acknowledges FDA communication breakdowns

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(WASHINGTON) -- FDA's Deputy Commissioner for Food Policy and Response, Frank Yiannas, has announced he is resigning from his post. His departure comes in the wake of last year's infant formula shortage, throughout which Yiannas held a prominent leadership role.

The decision also comes amid the ongoing HHS-OIG audit into whether the FDA responded adequately to the mounting crisis, as ABC News was first to report -- and whether the agency followed proper recall protocol once a deadly bacteria had been detected inside Abbott's Michigan formula plant.

Additionally, the FDA is preparing to give an update later this month on steps it plans to take to strengthen its foods program, following an independent review that found it lacks leadership and mission clarity.

An FDA spokesperson tells ABC News that "by the end of February," they will also offer additional updates on how they're improving their organizational structure -- including how Yiannas' position responsibilities will be handled moving forward.

Yiannas had been in his role since December 2018. His resignation will be effective February 24, writing in a tweet he is "honored to have served the American public, alongside each and every one of you, over these past four years."

Yiannas was among the senior officials who was involved in responding to the formula crisis and admitted to lawmakers in May 2022 that a string of internal failures and communication breakdowns at his agency contributed to how bad the situation had grown.

Lawmakers and the public alike repeatedly pushed for further clarity on why it took so long for federal regulators to respond to the mounting crisis.

Months before Abbott's massive formula recall in February of last year, there had already been warnings about quality and safety concerns at the key facility.

There had been a whistleblower report alleging a "litany of violations" and safety issues at Abbott's key plant sent to the FDA in October 2021 -- however, as Yiannas said under oath before Congress in May 2021, he and other FDA leaders didn’t learn that report for months. The agency blamed their mailroom and called it an "isolated failure" that was "likely due to COVID-19 staffing issues.”

Yiannas said the complaint was not immediately escalated, and he didn't see it until mid-February, roughly four months after it had been sent.

By that time, as ABC News has reported, reports of infants getting sick and hospitalized after consuming Abbott's formula had already been emerging, including one who had already died -- in addition to the quality and safety concerns flagged at their Sturgis facility.

However, Abbott maintains none of the bacterial strains found at their plant matched the samples genetically sequenced from the hospitalized infants, and that there is no conclusive evidence that its products contributed to the ultimate death of two infants.

"Why is it then, if you're the deputy commissioner for food policy, you didn't get the report?" Rep. Gary Palmer (R-AL) asked during the previous May hearing. "How is it that it got tied up in bureaucracy and it didn’t get to the person who arguably should be responsible for responding to it?"

"Yeah, I'm not sure why the report wasn’t shared with me and how it didn't get escalated," Yiannas said. "As you’ve heard the commissioner state, I know there's going to be a review, and we're going to try to get to the bottom of it."

Yiannas' boss, FDA Chief Robert Califf, acknowledged the response to the formula crisis had been "too slow," and that "there were decisions that were suboptimal along the way."

In his resignation letter, tendered to Califf on Wednesday, Yiannas does not own any responsibility for the agency's missteps during the formula crisis -- rather, he touts his achievements.

"In February 2022, as you rejoined the agency, I shared with you that I was considering leaving, expressing my concern that the decentralized structure of the foods program that you and I both inherited, significantly impaired FDA’s ability to operate as an integrated food team and protect the public," Yiannas' letter says.

"It was also in February of 2022 that I first learned of the infant formula incidents that had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facility now reopened, infant formula availability more prevalent, and – very importantly - the necessary monitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position."

In a statement to ABC News, the FDA thanked Yiannas for his "service and dedication."

"The FDA can confirm Frank Yiannas has resigned from his position as deputy commissioner for Food Policy and Response effective February 24. The agency thanks Mr. Yiannas for his service and dedication to the FDA’s public health mission," the agency said. "Mr. Yiannas has served as a valued member of the agency’s leadership team, spearheading important initiatives including the New Era of Smarter Food Safety to help create a safer and more digital, traceable food system for our country."

ABC News' Anne Flaherty contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


Support grows for a new approach to COVID vaccine schedule, as proposed by FDA

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(WASHINGTON) -- A panel of public health experts for the Food and Drug Administration convened for an all-day meeting on Thursday to discuss whether the U.S. is ready to start treating COVID boosters like an annual flu vaccine, a move that would normalize COVID shots as permanent public health upkeep.

Creating a yearly COVID shot schedule would mean updating the shot once a year and hoping that it matches whichever variant is circulating that upcoming winter season, similar to how the flu shot schedule works. No longer would public health agencies and vaccine companies attempt to reactively update the COVID vaccine when variants come on the scene.

It would also eliminate the two-shot primary series for most unvaccinated people, in favor of a mainstreamed program.

"This is a consequential meeting to determine if we've reached a point in the pandemic that allows for simplifying the use of current COVID-19 vaccines," Dr. David Kaslow, director of the FDA's Office of Vaccines Research and Review, told the group of advisors on Thursday.

Dr. Peter Marks, the FDA's vaccine chief, said the virus has evolved so rapidly that the FDA has constantly needed to revise its approach. Now, he said, it was time to determine if they could do that on a schedule rather than at the whim of the virus' evolutions.

"We're now in a reasonable place to reflect on the development of the COVID-19 vaccines to date to see if we can simplify the approach to vaccination in order to facilitate the process of optimally vaccinating and protecting the entire population moving forward," Marks said.

The goal, FDA officials said, would be to deliver simpler messaging in the hope of reaching more Americans.

The way it stands now, people get different numbers of vaccines depending on their age and prior vaccination status. For example, unvaccinated people get their initial series in two shots, a few weeks apart, while vaccinated people have been encouraged to get a booster every few months, depending on how old they are.

The plan proposed by the FDA is to recommend every American get a single shot every year, with a few exceptions.

It's based on the idea that the vast majority of Americans already have some immunity in their system, either because they've been exposed to COVID itself or gotten vaccinated.

"Presumably, at this point in the pandemic, most of the general U.S. population have been sufficiently exposed to spike protein, either to infection, vaccination or both, such that a single dose of a COVID-19 vaccine would induce or restore vaccine effectiveness," Kaslow said.

But older, high-risk and immunocompromised Americans could still be recommended to get two shots a year, as could young children when they reach the age eligible for vaccinations.

"It could be that more than one dose is needed for high-risk older adults, persons with compromised immunity and young children who have not yet been completely immunized. At this time, those risk based adjustments remain to be determined," Kaslow said.

Responding to the proposal, some experts on the panel emphasized that people who haven't had COVID or been vaccinated might still need to get two shots to shore up their immunity.

But the members were broadly supportive of the move to simplify the COVID vaccine schedule.

"I certainly support this approach. Simpler is better," said Dr. Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego and a member of the FDA's panel.

"I think this is definitely the way to go as soon as we can figure out how to do it," he said.

More data is necessary to decide exactly who will be protected enough by one dose, experts said.

"My general feeling from the committee is that we need more data to figure out exactly who should get the two-dose schedule, who should get the one," said Dr. Stanley Perlman, an infectious disease expert with the University of Iowa and a member of the panel.

"So all that kind of information will help determine this immunization schedule, but in general principle, the committee was supportive of going forward with this," Perlman said.

The FDA will likely not make any concrete decisions until later in February, after a panel of experts at the Centers for Disease Control and Prevention has a similar public discussion on the newly-proposed schedule.

And just which variants the updated booster would target for next season won't be decided until this summer, likely in early June, for distribution sometime in the fall.

Of course, the reality is that a small percentage of Americans have opted to get the current booster — around 16%, despite recent CDC research showing that it can cut risk of symptomatic infection by around half. And because less and less people have opted for a booster shot each time one has been recommended, the appetite could be lower by next fall.

But Marks, the FDA's vaccine chief, was optimistic that aligning the COVID vaccine on a yearly schedule with the flu shot could encourage more people to make it a routine.

"If we can see the influenza vaccine and the COVID-19 vaccines occurring at the same visit, it facilitates a vaccination program that may lead to more people getting vaccinated and being protected, and reducing the amount of disease we see," Marks said.

"So I think that overall, this seems like a reasonable way to go."

ABC News' Nicole Wetsman and Youri Benadjaoud contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


FDA says new process is needed for regulating CBD products due to risks

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(WASHINGTON) -- The U.S. Food and Drug Administration announced Thursday that it will not review or allow the marketing of cannabidiol, or CBD, products as food items or dietary supplements.

Up until recently, the health agency has not allowed any company to make claims about health benefits from wellness CBD products.

The FDA said after "careful review" it has determined that its current framework for evaluating food and supplements is not set up well for CBD because of safety risks and that substances, including CBD, have to meet specific safety standards to be lawfully marketed as a dietary supplement or a food additive.

"The use of CBD raises various safety concerns, especially with long-term use," FDA Principal Deputy Commissioner Dr. Janet Woodcock said in a statement. "Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system."

The statement continued, "CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant."

Woodcock said animals are also at risk of side effects from CBD. People might not know they've been exposed to the ingredient if they consume meat, milk and eggs from animals fed CBD, she said.

"Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food," she said.

The FDA said it plans to "work with Congress" to create new rules for regulating these products, which could include requiring clear labels, preventing contamination, content limits and even a minimum purchase age.

CBD and tetrahydrocannabinol, or THC, both come from the cannabis plant. While THC is the main psychoactive ingredient that gives users the "high," CBD is believed to behind therapeutic effects associated with marijuana such as relief from nausea and pain relief.

The agency also announced it is denying three petitions submitted by citizens asking CBD products to be marketed as dietary supplements.

"Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives," Woodcock said. "For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods."

ABC News' Eric Strauss contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


Record number of deaths in US from cardiovascular disease early in pandemic: Report shows

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(NEW YORK) -- New data from the American Heart Association highlights the major impact COVID-19 had on cardiovascular health and death rates during the first year of the pandemic.

At least 928,741 Americans died from cardiovascular disease-related causes in 2020, the annual statistical report revealed. That represents the largest one-year increase since 2015 and tops the previous high of 910,000 deaths recorded in 2003, according to the American Heart Association.

"This is our first real evidence based on the impact of the early years of the pandemic," Dr. Connie Tsao, chair of the Statistical Update writing group and assistant professor of medicine at Harvard Medical School, said.

It's something experts had predicted.

"This was not surprising," Dr. Michelle Albert, volunteer president of the American Heart Association and chair in cardiology and professor of medicine at the University of California at San Francisco, told ABC News.

COVID-19 had both direct and indirect impacts on the increased rates of cardiovascular disease-related deaths, experts said.

Cardiovascular disease and risk factors may be linked to COVID-19 severity and mortality, and the virus itself may have exacerbated certain symptoms in people with cardiovascular disease. The precise relationship between the two still requires more research, experts said.

COVID-19 indirectly impacted cardiac health too – early on people avoided doctor's offices and hospitals.

"We went into isolation. People were afraid to come into the hospital for care and when people showed up for care they showed up with more advanced disease," Albert said.

Asian, Black, and Hispanic communities were disproportionately impacted by the deaths seen in 2020, which also reflects the toll of the pandemic, she said. Those groups already had worse cardiac health outcomes because of socioeconomic issues, bias and lack of access to quality health care.

"As we look at groups that are traditionally disadvantaged and carry a disproportionate share of health disparities, the pandemic further amplified their disadvantages," Albert said.

The report also pointed to other factors beyond COVID-19 that contributed to deaths from cardiovascular disease in 2020.

Low rates of exercise in adults and teenagers continue to be a concern. Only about 1 in 4 Americans meet both the muscle-strengthening and aerobic exercise guidelines, and less than half of high school students exercise for at least an hour a day, five days a week, according to the report.

Data also showed that women were more at risk of heart disease complications or death than men. They were less likely to undergo procedures to treat conditions like heart attacks and less likely to be prescribed medication to lower cholesterol.

Experts pointed to a few ways people can take more control of their cardiac health in light of those findings.

In terms of physical activity, even if they're not quite meeting the recommended amount of exercise, something is better than nothing.

"The real message, especially in people who may be older adults and come from a habit of being sedentary, is that it's good to get some physical activity even if you don't meet the goals laid out," Tsao said.

For women, according to Albert, it's imperative to be educated about heart disease. Women mistakenly think of cancer as a bigger risk for them than heart disease, when the converse is actually true.

The presentation of a heart attack may slightly differ in women relative to men, and it is important that women be aware of the totality of possible symptoms, said Albert.

"Traditionally speaking, when we think about the symptoms of heart attack, for example, patients think about chest pain, chest pressure, pain moving down to left arm and those are symptoms that have been classically learned from research in men," Albert said. "But women are more likely to have symptoms related to gastrointestinal tract, like indigestion, or shortness of breath and ignore it."

Pregnancy can also, uniquely, serve as a window into women's cardiovascular health, according to Albert, as well as an opportunity to get screened for cardiovascular risk factors before and during the pregnancy.

Diet can also promote heart health, experts said. The Mediterranean diet — which emphasizes plant-based food, healthy fats, moderate amounts of fish and lean meats — is linked with lower rates of and risk from cardiovascular diseases.

Sleep is also an important "life essential," the heart association said. People's quantity and quality of sleep may impact their cardiovascular health.

While individual lifestyle choices are important contributors toward the risk of cardiovascular disease, the report highlights larger inequities that have propagated worsened health outcomes in certain groups.

Individuals living in lower income communities experienced greater obstacles in receiving life-saving care if they have cardiovascular health problems, as well as having access to resources that may help in preventing these conditions. Experts said they are working to understand why these risks exist in more vulnerable populations and to advocate for more funding for research and structural and policy changes.

Cardiovascular disease is the No. 1 killer globally, and it'll take targeting both individual and societal factors to bring numbers down, Albert said.

"Despite the statistics people should not feel helpless," she said. "I think there is hope, but I don't see the numbers changing without societal changes as well."

Eden David studied neuroscience at Columbia University and is currently a third-year medical student and a member of the ABC News Medical Unit.

Jennifer Miao, MD, is a fellow physician in cardiology at Yale School of Medicine/Yale New Haven Hospital and a member of the ABC News Medical Unit.

Copyright © 2023, ABC Audio. All rights reserved.


Only about half of US adults are meeting physical activity guidelines: CDC

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(ATLANTA) -- Only about half of adults in the United States are meeting physical activity guidelines set by the Centers for Disease Control and Prevention, new research shows.

The report, published Thursday by the CDC looked at the percentage of American adults aged 18 and older who are getting 150 minutes of moderate exercise and two days of muscle strengthening per week.

Moderate exercise includes any activity that gets the heart beating faster and muscle strengthening includes anything that makes muscles work harder than usual.

Researchers analyzed data from the 2020 National Health Interview Survey data to see if adults were meeting the guidelines across regions of the U.S. and in urban vs. rural areas.

Just 46.9% of adults across the country are currently meeting one of those guidelines.

The team then compared differences in meeting guidelines in the Northeast, Midwest, South and West.

Adults living in the West were the most likely to meet both guidelines with 28.5% performing the weekly recommended guidelines. Meanwhile adults in the South were the least likely at 22%.

The same held true when breaking up the guidelines into two sections: aerobic and muscle-strengthening.

Those living in the West were most likely to meet both with 52% performing 150 minutes of aerobic exercise a week and 35.3% performing strength training two days a week.

Southern adults were the least likely with 43.3% meeting aerobic guidelines and 29% meeting strength training guidelines.

When it came to seeing who was meeting guidelines by urban-rural classification, adults in large central metros -- such as New York City, Chicago and Miami -- were the most likely to meet both guidelines at 27.8%. These adults were also most likely to meet individual guidelines with 50% for aerobic and 35.2% for muscle-training.

Adults in rural areas were the least likely with 16.2% meeting both, 38.2% meeting aerobic and 21.1% meeting muscle-strengthening.

Researchers say the findings are concerning because not getting enough physical training can lead to several diseases that increase the risk of death including obesity, heart disease, type 2 diabetes and cancer.

Meanwhile, physical activity has several health benefits such as improving sleep, cognition and bone and musculoskeletal health while reducing the risk of dementia, according to the CDC.

The U.S. has launched national efforts such as the CDC's "Active People, Healthy Nation," with a goal of helping 27 million Americans become more physically active by 2027. The U.S. Department of Health & Human Services has also launched "Move Your Way," encouraging Americans to start moving, adding that any amount is better than none.

However, such efforts "require ongoing, detailed surveillance to understand geographic disparities in meeting guidelines," according to the authors.

"This body of…evidence is important for understanding rural-urban disparities in physical activity and tracking the attainment of national objectives; however, it is only the first step," the team wrote in the report.

"A national paradigm shift is needed to build structural capacity through investments in human, informational, organizational, fiscal, and physical resources (and to implement policy, systems, and environment changes to impact population level physical activity across the United States, and especially outside of large metropolitan areas," they continued.

Copyright © 2023, ABC Audio. All rights reserved.


As US reels from multiple mass shootings, can loneliness be a trigger for violence?

Emily Fennick / EyeEm/Getty Images

(NEW YORK) -- There is a loneliness epidemic in the United States -- and it experts told ABC News it may be triggering violence.

In California, there have been three shootings in as many days, tied to a perpetrator who may have exhibited signs of social isolation and/or violent behavior, according to authorities.

In Monterey Park, police documents revealed the 72-year-old suspect had been divorced from his wife since 2006, lived alone in Hemet -- about 30 miles Southeast of Riverside -- and was angry and resentful.

A former tenant and longtime acquaintance of the shooter, who wished to remain anonymous, told ABC News that he liked to dance but that he didn't have many friends at either of the dance studios he allegedly targeted.

The suspect "distrusted everyone," the acquaintance said, adding, "I wouldn't say he was aggressive, but he just couldn't get along well with people."

In the Half Moon Bay shooting, the man accused of killing seven farmworkers had a history of making threats after losing his job at a restaurant, according to ABC News local affiliate KGO-TV.

According to court documents, a former coworker and roommate filed a restraining order against the suspect after he allegedly threatened to kill him. The suspect allegedly tried to suffocate him by putting a pillow over his face if he didn't help the suspect get his job back.

Experts said although there is not a lot of research on isolation, there appears to be a link between loneliness and violence, experts said.

"Clearly isolation and loneliness are at play in a lot of violence," Dr. Edwin Fisher, a psychologist and professor in the department of health behavior at Gillings School of Public Health at the University of North Carolina, told ABC News. "They may be important red flags for us to recognize and trying to help people who are prone to violence."

Fisher said there are many types of violence that social isolation and loneliness are related to, including sexually soliciting minors online, intimate partner violence, cyber bullying -- and homicide.

"Grievance and perception of self as a victim, I think both of those are present in the mass murders in California these past few days," he said. "So, in addition to being socially isolated and feeling lonely, feeling grievance, feeling victimized, I'm going to finally pay them back, may be really important in some kinds of violence."

Loneliness epidemic among men

Loneliness perpetrating violence may be affecting American men more than women due to males suffering a "friendship recession."

According to data from the American Enterprise Institute's Survey Center on American Life in 2021, the percentage of men reporting at least six close friends declined by half from 55% in 1990 to 27% in 2021.

The percentage of men reporting no close friends rose five-fold from 3% in 1990 to 15% in 2021. What's more, one in five single men say they don't have any close friends.

On the other hand, women are much more likely to report having close friends and relying on those friends for emotional support, the survey found.

According to the Centers for Disease Control and Prevention, men had a suicide rate four times higher than women in 2020. Men make up 49% of the U.S. population but nearly 80% of suicides, CDC data shows.

"One could speculate that there's something that ties male loneliness to violence," Dr. Nathaniel Glasser, a research fellow and clinical instructor of medicine at the University of Chicago Medicine, told ABC News. "That in situations where boys and men feel loneliness, they -- not always, but occasionally, arguably too frequently -- turn to violent mechanisms to reconcile or cope or otherwise deal with their loneliness."

Glasser pointed to ads from a firearm manufacturer for an assault rifle, one of which read, "consider your man card reissued."

"That's exactly the language that some gun manufacturers use -- or have used -- to speak to men, saying that guns are a way for males trying to reclaim some kind of image of masculinity to do so," he added.

Dr. Elizabeth Tung, a social epidemiologist and assistant professor of medicine at the University of Chicago, agreed.

"There is just so much speculation, but I think there's also like this threat of societal emasculation and men who are lonely and emasculated trying to recapture their masculinity in some ways," she told ABC News.

Experts, such as Dr. Niobe Way, believe the rise of male loneliness may be a factor in the rise of violence.

Way, a professor of developmental psychology at New York University Steinhardt School of Culture, Education, and Human Development, has studied boys through adolescence. She said when they're younger, around age 12 or 13, they talk about wanting close friendships and emotional intimacy.

However, as they get older and start experiencing expectations of traditional masculinity, "they start disconnecting form their desires and feeling much more isolated," she told ABC News.

"The disconnection, the loss that no one seems to care that our boys are feeling isolated," Way, author of Deep Secrets: Boys' Friendships and the Crisis of Connection, said. "They start to disconnect from their own humanity because they're not able to find the relationships they want, and many are depressed and angry about it."

Violence also leading to loneliness

Tung said the opposite can be true as well, meaning being exposed to violence can also lead to loneliness.

A study she co-authored in 2019 found that adults living in Chicago neighborhoods with high rates of violent crime are more likely to be lonely than the average American.

"We found was that there's a really strong relationship between any kind of exposure to violence, whether it's direct or indirect police violence, community violence, and being more isolated, as well as being lonelier," she told ABC News. "It's interesting, because the state of isolation and loneliness in the U.S. is already much higher than it was 50 years ago … and so the fact that violence exposure is associated with an even greater augmentation of that statistic is pretty alarming."

In this case, the theory is that community violence increases distrust and suspicion, leading to further isolation and loneliness.

Access to guns

This is all coupled with widespread access to guns in the United States, experts said.

A Pew Research Center survey in 2021 found that four in 10 adults in the U.S. live in a household with a gun, while 30% said they own a gun.

Federal data suggests gun sales have spiked, especially during the COVID-19 pandemic. On top of that, just 21 states and the District of Columbia require background checks on sales of some or all types of firearms, according to Everytown for Gun Safety.

Fisher said he is currently writing a chapter on social isolation and loneliness for the American Psychological Association, and one of the findings show the importance of gun control.

"One of the findings of the chapter is how global the research is studies from Asia, Africa, Europe, North and South America, all over the world, social isolation and loneliness are problems," he said. "Only in the United States are they leading to many mass murders."

Solving the problem

So how do we combat the problem of loneliness? The experts say there are a few ideas.

"There's a lot of research about really pushing this idea of social prescribing," said Tung. "Helping older people make more social connections, we can prescribe like somebody going to a senior center and joining some kind of community activity."

"But there is a broader cultural thing going on, especially with technology, and if more and more people are spending all of their time connecting through technology rather than in person, I worry that the idea of social prescribing or health care prescriptions for social activities is a little too simplistic," Tung added.

There's also making sure that people are having robust and varied social interactions that might help pump the brakes on exhibitions of violent behavior, experts said.

"So, when we're talking about people who are isolated, we want to try to be thinking in terms of encouraging varied social connections, and healthy social connections, if you will, as opposed to the community of, you know, child abusers that they're connected with on the web," Fisher said.

He also added that being kind can be just as important as a long talk.

"A really important point is that social connection does not necessarily need to be, deep, intimate conversations over hours and hours," he said. "Casual contacts can be very important in just making us feel connected. So, if you see people who seem to be lonely, who seem perhaps a little bit brittle or disgruntled, kind words can do a lot. It's far from a solution, but it helps."

Copyright © 2023, ABC Audio. All rights reserved.


Physician weighs in on how patients, doctors can improve their trust

ABC News

(NEW YORK) -- One of the most important aspects of medicine is the relationship between a doctor and their patient, according to physician and Yale School of Medicine professor F. Perry Wilson.

However, Wilson said that relationship has been strained in recent years and has led to complications in treating people.

Wilson spoke with ABC News Live Tuesday about his new book, How Medicine Works and When It Doesn't: Learning Who to Trust to Get and Stay Healthy, and gave tips on how people can improve this relationship.

ABC NEWS LIVE: So it's January. Everybody has their ideas of getting healthy, and there are a lot of tips and tricks for that. You point actually, though, to the medical system itself is kind of being responsible for some of those gimmicks, if you will.

DR. F. PERRY WILSON: Yeah, well, part of the problem is that people are pushed away from [the] medical system and from good knowledge because a lot of times the health system itself is failing to meet their real needs. We have frustrations with insurance companies, [and] with pharmaceutical companies. You don't have enough time to see your doctor because your doctor is working for a corporation that is telling you to see more and more patients all the time. And what this frustration leads to is people running away from good science-based, [and] evidence-based medicine and into the arms of people that might not have their best interests at heart promoting unsafe practices. And that can be really bad for your health. We've got to sort of change that framework.

ABC NEWS LIVE: You write, "The most powerful force in medicine is trust." Explain what you mean by that and where you feel like the breakdown in trust comes from.

WILSON: Yeah, well, that relationship between a patient and their doctor, we call it the Therapeutic Alliance. And I actually like that term because it makes me feel like we're in kind of a battle against disease. And what that takes is a real deep bond of trust. I have to trust that you're telling me the truth. You're being open with me about what's bothering you and what you're up to. And you have to trust me that I have your best interests at heart. And when we are trying to work within a framework that is profit-driven, that is insensitive to the real needs of patients, well, that trust doesn't work anymore.

ABC NEWS LIVE: And when you talk about that trust between the doctor and patient relationship, how does one go about rebuilding that and even establishing it? Because I have to say, when I go into my doctor, I feel like it's like, I'm just on a clipboard. Okay. How are you doing? What's your weight? What's your height? You feeling OK? All right, onto the next person. So how do I actually have that relationship?

WILSON: Yeah, well, so it comes from both sides. For patients, they need to start to realize that a lot of the things they're seeing online on social media, what I call [an] easy fix or one simple thing, medicine. One dietary supplement to take to give you shredded abs or one exercise to alleviate depression. Those things aren't real. Real change takes work, and so patients have to move a little bit to understand that, that we're going to ask some tough things of you; real lifestyle change if you want to get healthy. At the same time, doctors need to start realizing that we're on the same side as patients. It is us and patients against this system.

And once doctors start to realize that they have more in common with their patients than they do with the C-suite executives who are writing their checks, we can see some real change.

ABC NEWS LIVE: What is good medicine as you define it here in the book?

WILSON: Well, good medicine comes from a number of things. It comes when people look at data and make their conclusions based on data as opposed to deciding what they want their conclusion to be and finding the data that fits. And we live in a world for better or worse. If you want to find data to support what you believe to be true or what you want to be true, it's out there. It may be false, but you can Google it. It's on social media. And so people, to make the best choices for their health, can't just decide what they want to conclude in advance. They have to actually come to it with an open mind and a good doctor. Practicing good medicine is going to help you ask those right questions.

ABC NEWS LIVE: What are those right questions, though? How would I know what I should ask?

WILSON: Well, the most important thing is to be honest about what's bothering you. And one question that I encourage doctors to ask their patients and the trainees that I work with [is] to ask their patients... "Are you lonely?" There's an epidemic of despair in the country right now. Death rates among people in the 35 to 55 age bracket who should be really living their best lives are increasing due to alcohol abuse, drug abuse and suicide. A lot of that is due to social isolation, loneliness, [and] despair, and doctors don't address those issues.

ABC NEWS LIVE: You know, people often say, be your best advocate. You are your best advocate. Right. And so how would you encourage someone? I guess it's kind of along those same lines as far as just being honest.

WILSON: [There are a] couple of things you can do. No. 1, you can ask this question: What else could it be? This is a question that reframes as a doctor. You're my 20th patient of the day. I just need to get out, I'm hungry, etc. That question flipped a switch in my mind. That's going to make me say, "OK, wait, OK, yeah, I think I know what's going on here, but you just ask, what else could it be?" And it forces me to take a step back and rethink the situation that can be really valuable information.

The other thing you can do is bring someone with you. It's the same as if you go to a mechanic or anyone else who has sort of expertise beyond what your level is. Having that other person there who's just kind of a step outside can lead to some better questions, and I've had great interactions with patients where I'm talking to the patient and he's nodding and yep, I get it. I agree. I understand. And his wife will kind of turn and say, "Do you get it? Do you know it? Did you hear what he just said?" And all of a sudden it becomes clear? No, you know, the communication wasn't there. So, bring an advocate, bring someone with you and make sure your doctor's OK. Having someone else in the room, they should be. If not, sometimes you've got to find a different doctor.

Copyright © 2023, ABC Audio. All rights reserved.


Conjoined twin sisters undergo successful surgery to separate

Courtesy of Cook Children's Medical Center

(FORT WORTH, Texas) -- Twin sisters who were conjoined at the chest and stomach have undergone successful surgery to separate.

Doctors at Cook Children's Medical Center in Fort Worth, Texas, announced Wednesday that 16-week-old sisters JamieLynn and AmieLynn are now sleeping in separate cribs after the separation surgery, the first surgery of its kind in the hospital's 150-year history.

The girls' parents, Amanda Arciniega and James Finley of Saginaw, Texas, said they learned via an ultrasound during pregnancy that they were expecting conjoined twins.

"On the ride home, we were quiet and it was kind of sad. We were thinking, 'Why us, out of everybody?'" Arciniega said in a video shared by Cook Children’s. "It's a lot."

Arciniega gave birth to her daughters in October at Texas Health Harris Methodist Hospital in Fort Worth. She was 34 weeks pregnant at the time and delivered her daughters via C-section, doctors said.

JamieLynn and AmieLynn were then transferred to Cook Children's neonatal intensive care unit, where they stayed until the separation surgery.

Only a small handful of conjoined twins survive past birth, according to Dr. Jose Iglesias, medical director of pediatric surgery at Cook Children's Medical Center and the lead surgeon for the twins' separation surgery.

"Conjoined twins that reach and stay viable after birth, at least for the first few days, there's really only about five or eight of those on the entire planet," he said. "So it is a very are situation."

Conjoined twins occur once in every 50,000 to 60,000 births, and approximately 75% of conjoined twins are female, according to the Children's Hospital of Philadelphia, which has completed more than two dozen separation surgeries.

A large team of doctors and nurses at Cook Children's prepared for three months for the surgery, which included surgeons, anesthesiologists, neonatal specialists and more.

"In order to prepare for this, it's a lot of practice, practice, practice and more practice, trying really to think of every possible scenario so that we're not surprised by anything," said Dr. Chad Barber, a neonatologist at Cook Children's. "There's always going to be unexpected things, but if you're prepared for the worst possibilities and the most unlikely outcomes, then you can at least hopefully not get caught too off guard."

The operation on Monday, which lasted 11 hours, involved separating the girls' liver as well as their skin, fascia and bowel, according to Dr. Ben Gbulie, a plastic surgeon at Cook Children's.

The medical team was divided into two teams to take care of the two girls, with AmieLynn’s team wearing green hats and JamieLynn’s team wearing purple hats during the surgery.

Following the surgery, Iglesias said doctors were able to close both girls' abdominal walls.

"They're both doing very well," he said. "The team performed phenomenally and we're just incredibly happy."

Describing the sisters' future, Iglesias added, "They’re going to grow up like the little girls they’re meant to be, independent and feisty, like they’ve already shown us."

Of the treatment at Cook Children's that his daughters received, Finley said, "It feels like we're at the best possible place we can be. I wouldn't want to be anywhere else."

"We're family here," added Arciniega.

Copyright © 2023, ABC Audio. All rights reserved.


COVID-19 vaccines are safe and effective for kids, according to new data

Images By Tang Ming Tung/Getty Images

(NEW YORK) -- Two doses of the mRNA COVID-19 vaccine among school-aged children safely and effectively reduces COVID-19 infection risk as well as associated risks for developing multisystem inflammatory syndrome and COVID-19 related hospitalizations, new data suggests.

This study adds evidence to existing studies and "supports the safety and efficacy of mRNA COVID-19 vaccine in children aged 5-11 years," authors Dr. Jun Yasuhara of the Center for Cardiovascular Research at Nationwide Children's Hospital and Dr. Toshiki Kuno of the Division of Cardiology at Montefiore Medical Center told ABC News.

Researchers at Nationwide Children’s Hospital and Montefiore Medical Center analyzed rates of COVID-19 infection, symptom severity and vaccine side effects among 10,935,541 vaccinated children aged 5 to 11 years compared to 2,635,251 unvaccinated children.

They found vaccinated children had lower rates of infection and less severe symptoms if they did end up infected. Severe reactions to the shot were rare and any local injection irritation went away after several days. The low rates of severe side effects should be reassuring for parents and guardians worried about adverse events following vaccination, according to the study's authors.

The study also found only a small increase in risk for kids to develop inflammation of the heart (myocarditis) after COVID-19 vaccination. It found that there are 1.8 cases of myocarditis per million children who get two doses of the vaccine, a comparable or slightly higher rate than in children diagnosed with myocarditis before the COVID-19 pandemic.

But the risk of myocarditis after getting sick with COVID-19 is far higher than after getting the vaccine, according to Kuno and Yasuhara. Furthermore, kids are less likely to survive if they get COVID-19-related multisystem inflammatory syndrome, a rare condition associated with the virus, compared to those who developed myocarditis after mRNA vaccination.

Despite the vaccine’s safety, too few children are getting vaccinated. A report from the Centers for Disease Control and Prevention released in January found overall low rates of vaccination coverage among children and adolescents between 5 and 17 years old. The report also revealed racial disparities in COVID-19 vaccination status for adolescents and children. Vaccination coverage among Black children aged 5-11 years was lower than that among Hispanic, Asian and other minority children.

In another study, only one in five parents of school-aged children said their child either received the updated COVID-19 booster or will definitely be doing so, while 9% reported their child will probably receive a booster. This is in contrast to the 61% of parents who stated their child remained unvaccinated and thus ineligible for the booster.

There are many reasons why parents are reluctant to get their kids vaccinated against COVID-19, according to Dr. Angela Myers of the Infectious Diseases Division Director at Children’s Mercy Kansas City in Kansas City, Missouri.

That includes a misconception that the vaccine is not effective because it doesn’t block all infections, Myers said.

"Instead [it] protects against severe infection, hospitalization and death," she said.

Myers said parents should talk to their child’s pediatrician if they have questions about the vaccine.

"Despite vaccine hesitancy and sometimes refusal, the child’s primary care clinician is still the best place to get the best, most up-to-date, information," she said. "Pediatric clinicians want what’s best for all children and data has shown that they remain the most the most trusted source of information for parents making vaccine decisions."

Copyright © 2023, ABC Audio. All rights reserved.


How to talk to children following mass shootings in California, Washington

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(NEW YORK) -- As news continues to unfold following multiple deadly mass shootings within the last few days in California and the state of Washington, experts are advising parents not to shy away from talking to their kids about what happened and the aftermath.

At least 11 people were killed and nine were injured after a gunman opened fire Saturday night at Star Ballroom Dance Studio in Monterey Park, California. In northern California, seven people were killed after shootings at two farm locations in Half Moon Bay on Monday.

Early Tuesday, another shooting broke out at a Circle K convenience store in Yakima, Washington, leaving three people dead and a possible fourth person injured.

ABC News chief medical correspondent Dr. Jennifer Ashton shared tips on how families and caregivers can talk to young people about mass shootings last July on GMA3.

Read on to see her advice -- and tips from other experts -- on how to discuss sensitive issues with your kids:

Start an age-appropriate conversation

"The first step is to make an age-appropriate dialogue, open lines of communication with your child," Ashton recommended.

Dr. Robin Gurwitch, a licensed clinical psychologist and Duke University professor who specializes in speaking to children about trauma and disasters, agrees. Parents and caregivers should "be willing to bring this topic up," Gurwitch told GMA last May.

"We really want to want to wrap our arms around them and make them feel safe," Gurwitch said at the time. "But part of being a parent is willingness to discuss difficult topics."

Gurwitch added that it helps to discuss the topic in a calm manner, listen to children's perspectives and concerns, ask and respond to questions, and reassure them whenever possible.

Ashton also encouraged parents to lead with honesty and transparency and to not be afraid to say "I don't have an answer" or share their feelings.

"We shouldn't sit back and wait for them to come up and say, 'Mom, Dad, I'd like to talk about gun violence,'" Ashton continued. "We're going to need to take the first step and come to them early and often and say, 'What are you thinking about? What are you afraid of? What questions do you have?'"

Ashton suggested that adults offer a solution, such as, "'I don't have an answer to that but I'll help you find it. I know you're scared, so am I, but let me tell you what your teachers and what your parents and community are trying to do to help you stay safe.'"

Monitor children's behavior

Psychiatrist and author Dr. Janet Taylor and Gurwitch both said children can respond to disturbing news about mass shootings in different ways and parents should pay attention to see if their child's behaviors change. Children can experience problems focusing, sleeping or become more irritable.

"If you have younger children and they suddenly get more clingy or want to sleep in bed with you, pay attention to that and cuddle them as they need it," Taylor told GMA in 2022. "Older kids may become more isolated or feel that they have to solve things by themselves."

Practice stress reduction techniques

News of mass shootings can negatively impact children and adults and trigger anxiety and other feelings of stress. Author Rachel Simmons said breathing exercises can help for kids but also for parents, who can model the practice.

"You can take a deep breath, count to three, hold it for three and then let it out for three, so it's nine seconds of breathing in ... and breathing out," Simmons told ABC News in 2019. "Do it three times. They can kind of drop back into their bodies and feel a lot calmer."

Remember to check in

Instead of discussing a mass shooting only once, Gurwitch said it's crucial to continue the conversation over time.

"A one-and-done conversation is not sufficient," she said. "Let your child or teenager know that 'I really do care about you and I am open to having this discussion.'"

Get professional help

If a child's stress levels or response to a mass shooting are hard to manage, doctors say parents shouldn't hesitate to seek guidance from their pediatrician, a local psychological association, a counselor, social worker or other mental health experts and community leaders.

Licensed psychologist Dr. Sanam Hafeez also pointed out that if a parent or caregiver is struggling themselves, they should not wait to seek help.

"Psychologists, psychiatrists, mental health professionals like myself are available on telehealth ... so if you feel that your anxiety is at an all-time high from not just coping with the stressors that are facing us but from mass shootings ... if you feel that your anxiety is where you are really afraid to go back into the real world and you're missing out on life, it's time to seek help," Hafeez told ABC News in 2021.

The National Child Traumatic Stress Network offers comprehensive resource guides for parents, caregivers and educators to support students. Click here for resources related to school shootings.

Copyright © 2023, ABC Audio. All rights reserved.


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